Clinical Trial: Human Papillomatosis Genotyping of Children in Thailand

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand

Brief Summary: The purpose of the present study was to identify risk factors for more severe juvenile Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity using above mentioned staging system at the time of each endoscopic debridement, as well as human papilloma virus (HPV) genotyping.

Detailed Summary:

Recurrent respiratory papillomatosis is caused by human papilloma virus and is the most common benign laryngeal neoplasm in children. Although RRP is rarely fatal, the disease requires prolonged, extensive medical and surgical treatment, and causes physical and emotional suffering in affected children and their families. Although recurrent respiratory papillomatosis is a relatively unusual problem, it accounts for significant health are expenditures.The goal of management of RRP is control of the disease, preservation of the voice and prevention of major complication .The purpose of study will identify risk factors for more severe juvenile RRP through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity , as well as HPV genotyping.

Objective:

  • To identify the genotypes of HPV isolated from Thai RRP patients
  • To compare staging and severity with HPV genotypes
  • To correlate the following characteristics of the Thai RRP patients with the HPV genotypes

Sponsor: Queen Sirikit National Institute of Child Health

Current Primary Outcome: Human Papillomavirus Genotypes [ Time Frame: 12 months ]

Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy


Original Primary Outcome:

Current Secondary Outcome: Cotreta-Derkay Score [ Time Frame: 12 months ]

We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes

Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.

Coltera-Derkay method of staging :

Clinical score:

  1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2
  2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2
  3. Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.

Anatomical score:

For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.

Total score = Anatomical score + Total clinical score



Original Secondary Outcome:

Information By: Queen Sirikit National Institute of Child Health

Dates:
Date Received: February 25, 2011
Date Started: March 2011
Date Completion:
Last Updated: January 1, 2014
Last Verified: October 2013